Lipocine. has been granted a patent for a fixed dose oral testosterone undecanoate composition designed for testosterone replacement therapy. The patent outlines specific criteria for continuing or discontinuing treatment based on serum testosterone concentration levels measured after a set period following administration. GlobalData’s report on Lipocine gives a 360-degree view of the company including its patenting strategy. Buy the report here.
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According to GlobalData’s company profile on Lipocine, Nanoparticle drug conjugates was a key innovation area identified from patents. Lipocine's grant share as of June 2024 was 46%. Grant share is based on the ratio of number of grants to total number of patents.
The granted patent US12011503B1 outlines a pharmaceutical composition of Testosterone Undecanoate (TU) designed for the treatment of hypogonadal males. The claims specify a regimen for oral administration that aims to restore testosterone (T) levels to an effective concentration. A key feature of the regimen is a continuation criterion based on serum testosterone concentration levels measured 8 to 9 hours after administration, approximately 3 to 4 weeks post-initiation. If the measured testosterone level falls within the range of 300 ng/dL to 1080 ng/dL, the treatment continues; otherwise, it is discontinued. The regimen may involve daily doses of 450 mg of TU or twice-daily doses of 225 mg, with the latter typically administered in two capsules of 112.5 mg each.
Additionally, the patent claims that the composition should achieve a responder rate of at least 75%, indicating a significant proportion of patients will experience an increase in average testosterone levels (T Cavg) in response to the treatment. The claims also detail various parameters for monitoring testosterone levels, including the possibility of administering the composition with food or as an untitrated dose regimen. The increase in T Cavg can vary, with specified minimum increases ranging from 30 ng/dL to over 800 ng/dL. Overall, the patent provides a structured approach to managing testosterone therapy in hypogonadal males, emphasizing the importance of monitoring and adjusting treatment based on individual serum testosterone responses.
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GlobalData Patent Analytics tracks bibliographic data, legal events data, point in time patent ownerships, and backward and forward citations from global patenting offices. Textual analysis and official patent classifications are used to group patents into key thematic areas and link them to specific companies
